<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20190615043899N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-07-16</date_registration>
      <primary_sponsor>Boushehr University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of preemptive analgesic effect of Naproxen, Celecoxib and Acetaminophen codeine on pain control after mandibular third molar surgery</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of preemptive analgesic effect of Naproxen, Celecoxib and Acetaminophen codeine on pain control after mandibular third molar surgery in patients to dentistry clinic of bushehr university of medical sciences</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>78</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/40314</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are divided into three groups of 24 patients using randomized block method. According to random block allocation method, first, the volume of each block is determined, in this study, 12 blocks of 6 blocks were determined. After the block list was prepared, a number was allocated to each block. Then, random numbers were chosen between 1 and 12, and the random allocation list was selected according to the order of random numbers, Blinding description: The way of blinding was this: the drugs were embedded in insulating glasses of light and temperature and encoded under sterile gamma rays under laboratory conditions. The sample code was revealed after the study was completed and the results were revealed. Delivery of the drug to the patient and follow up of the patient's condition by someone other than the surgeon. The method of administration of the drug on the label of the drug was determined to be patient; who took the drug for three days according to the instructions, ie, naproxen 250 mg every 6 hours, celecoxib 100 mg every 12 hours and acetaminophen 325 mg every 6 hours.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Control of pain after third molar surgery.</hc_freetext>
      <i_freetext>Intervention 1: Control group: In this study, acetaminophen codein was used as a standard dose (control) to evaluate the efficacy of other drugs; So, half an hour before, surgery was given to a group of acetaminophen 325 mg. Intervention 2: Intervention group: Half an hour before surgery,  naproxen 250 mg (Pars Dara Company) was givenby this group. Intervention 3: Intervention group: Half an hour before surgery, another group took100 mg celecoxib (Darupakhsh, Tehran).</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Only part of the data, such as the key outcome information or the like, can share

When:
Start the access period 6 months after printing the results

To whom:
Only for researchers working in academic and scientific institutions

Conditions:
Not allowed

Where to obtain:
Dr seyed mehdi hosseini
pmn.hsn30067@gmail.com

How to obtain:
A week after the request

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyed Mehdi Hosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 1, Line 332, Deadlock 4, Imam Blvd</address>
        <city>Bushehr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>75167-96479</zip>
        <telephone>+98 77 3344 8061</telephone>
        <email>pmn.hsn30067@gmail.com</email>
        <affiliation>Boushehr University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyed Mehdi Hosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 1, Line 332, Deadlock 4, Imam Blvd</address>
        <city>Bushehr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>75167-96479</zip>
        <telephone>+7 733448061</telephone>
        <email>pmn.hsn30067@gmail.com</email>
        <affiliation>Boushehr University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patient OPG to confirm that the hardness of the lower third molar is the same. 
Patient-patient pain rating
History of systemic diseases
Patient should not have a history of hypersensitivity to steroid drugs
Patient in the range of 18 to 60 years old
Avoid taking an hour before taking analgesic 
 A person can read and understand the checklist 
The patient does not take analgesic because of chronic pain</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>There is an infection of the postoperative dry socket
Diabetic patients
Systemic drug interactions with the three drugs in this study
Use of psychological drugs
The presence of rotting teeth or needing treatment in the mouth
Lack of cooperation for future referrals
Systemic disease
People who had started treating the wound of the gastrointestinal tract for 30 days before surgery
Used analgesics or another drug for 24 hours before surgery
History of narcotic or analgesic addiction
Patients who were pregnant or Breastfeeding
Known sensitivity to anti-inflammatory drugs, non-steroidal anti-inflammatory drugs ordinary or cyclooxygenase-2 inhibitors</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>XIX</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Injury, poisoning and certain other consequences of external causes</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: In this study, acetaminophen codein was used as a standard dose (control) to evaluate the efficacy of other drugs; So, half an hour before, surgery was given to a group of acetaminophen 325 mg.</i_keyword>
      <i_keyword>Intervention group: Half an hour before surgery,  naproxen 250 mg (Pars Dara Company) was givenby this group.</i_keyword>
      <i_keyword>Intervention group: Half an hour before surgery, another group took100 mg celecoxib (Darupakhsh, Tehran).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The severity of pain. Timepoint: The severity of pain was the patient who was recorded in the questionnaire during the prescribed hours (7 days and 72, 48, 24, 12, 8, 4). Method of measurement: The severity of pain was as follows: the patient, based on her sense of pain, determined a number between 10-1 according to the definition of the pain states based on the degree of discomfort / pain. The number 1 indicates that the patient feels good and does not feel pain, and the number 10 indicates a painful pain, to the extent that the patient leaves all his work and feels the need for rest.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Boushehr University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-02-18</approval_date>
        <contact_name>Ethics Committee of Bushehr University of Medical Sciences</contact_name>
        <contact_address>No. 1, Line 332, Deadlock 4, Imam Blvd Bushehr Boushehr Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
